job description
Join Altek Medical as a Process Engineer and be at the forefront of revolutionizing medical technology in Southeast Asia. This is a unique opportunity to work with groundbreaking innovations in a dynamic, fast-paced environment. Based in the vibrant hub of Denpasar, Bali, you’ll collaborate with a multidisciplinary team to optimize manufacturing processes, enhance product quality, and drive operational excellence in the medical device industry.
Altek Medical is committed to advancing healthcare solutions through cutting-edge engineering. As a Process Engineer, you will play a pivotal role in scaling production, ensuring compliance with international standards (ISO 13485, FDA, CE), and implementing lean manufacturing principles to reduce waste and improve efficiency. If you’re passionate about transforming healthcare through technology and thrive in a culture of innovation, this role is for you.
Enjoy a competitive salary, professional growth opportunities, and the chance to live and work in one of the world’s most sought-after destinations—Bali—where work-life balance meets career advancement.
Responsibility
- Develop, optimize, and document manufacturing processes for medical devices to ensure consistency, scalability, and compliance with regulatory standards (ISO 13485, FDA, CE).
- Lead process validation activities, including IQ/OQ/PQ protocols, to guarantee product quality and reliability.
- Collaborate with R&D, production, and quality teams to troubleshoot process deviations and implement corrective actions.
- Design and implement lean manufacturing and Six Sigma methodologies to reduce waste, improve yield, and enhance operational efficiency.
- Monitor key performance indicators (KPIs) such as cycle time, defect rates, and throughput, and propose data-driven improvements.
- Support the transfer of new products from development to full-scale production, ensuring seamless integration into existing workflows.
- Train and mentor production staff on best practices, standard operating procedures (SOPs), and safety protocols.
- Stay abreast of industry trends, emerging technologies, and regulatory changes to maintain Altek Medical’s competitive edge.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related field. Advanced degrees are a plus.
- Minimum 3-5 years of experience in process engineering, preferably in the medical device, pharmaceutical, or biotechnology industries.
- Strong knowledge of GMP, ISO 13485, FDA 21 CFR Part 820, and other medical device regulatory requirements.
- Proven expertise in process validation, DOE (Design of Experiments), and statistical process control (SPC).
- Proficiency in CAD software (SolidWorks, AutoCAD), MES systems, and data analysis tools (Minitab, Excel, Python).
- Excellent problem-solving skills with a track record of implementing cost-saving and efficiency-improving initiatives.
- Strong communication and project management skills to lead cross-functional teams.
- Fluency in English; knowledge of Bahasa Indonesia is a plus.